TWi Biotechnology, Inc. announced that it has completed the patient enrollment in a phase II trial of AC-201 for Gout Flare Prophylaxis (GFP) during urate-lowering therapy (ULT). This randomized, double-blind, placebo-controlled Phase II study is conducted in 8 major medical centers in Taiwan. This study includes patients with acute arthritis of primary gout and elevated serum uric acid. A total of 82 patients were randomized at a 1:1 ratio to receive 50 mg AC-201 or placebo twice daily in addition to the ULT during the 16-week treatment period.
"We are very pleased to have the patient enrollment completed ahead of schedule for the AC-201 GFP phase II study," said Dr. Calvin C. Chen, President of TWi Biotechnology. "This prompt completion signifies the urgent need for an effective and safe drug to reduce the occurrence of gout flare for patients who are receiving ULT. We are looking forward to the results of this study which will be available before the end of this year."
Prof. Chung-Tei Chou, Visiting Staff of Division of Allergy, Immunology, and Rheumatology in Taipei Veterans General Hospital and the Chief Principal Investigator of AC-201 GFP trial also commented "Starting urate-lowering therapy (ULT) usually triggers painful gout attacks, and there is a need for new therapies to prevent or reduce the occurrence of these flares. AC-201 is an oral medication targeting the IL-1 mediated pathway involved in gout flares. I look forward to seeing positive results from this multicenter clinical trial in Taiwan."